Baclofen
- Product NDC
- 63187-313
- 11-digit product format
- 631870313
- Labeler code
- 63187
- Product ID
- 63187-313_83a0b967-118f-4459-ad38-1ec6a769dcc4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- baclofen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA077241
- Marketing category
- ANDA
- Marketing start
- 2005-12-01
- Substance
- BACLOFEN
- Active strength
- 10 mg/1
- Pharmacologic classes
- GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| H789N3FKE8 | BACLOFEN | 1134-47-0 | BACLOFEN |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 63187-313-20 | 63187031320 | 20 TABLET in 1 BOTTLE, PLASTIC (63187-313-20) | 20 tablet | 2018-10-01 | No | No | Historical |
| 63187-313-30 | 63187031330 | 30 TABLET in 1 BOTTLE, PLASTIC (63187-313-30) | 30 tablet | 2014-05-01 | No | No | Historical |
| 63187-313-60 | 63187031360 | 60 TABLET in 1 BOTTLE, PLASTIC (63187-313-60) | 60 tablet | 2014-05-01 | No | No | Historical |
| 63187-313-72 | 63187031372 | 120 TABLET in 1 BOTTLE, PLASTIC (63187-313-72) | 120 tablet | 2017-03-01 | No | No | Historical |
| 63187-313-78 | 63187031378 | 180 TABLET in 1 BOTTLE, PLASTIC (63187-313-78) | 180 tablet | 2018-03-01 | No | No | Historical |
| 63187-313-90 | 63187031390 | 90 TABLET in 1 BOTTLE, PLASTIC (63187-313-90) | 90 tablet | 2014-05-01 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| BACLOFEN TABLETS, USP | Proficient Rx LP | 2020-05-01 | HUMAN PRESCRIPTION DRUG LABEL | 8 |